Lung Cancer Exercise Training Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Memorial Sloan Kettering Cancer Center
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Duke University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01068210
First received: February 11, 2010
Last updated: April 6, 2016
Last verified: April 2016
  Purpose
The purpose of the study is look at the effects of different modalities of exercise training and its effect on post-surgical lung cancer patients. Subjects will take part in a 16 week training intervention that can consist of aerobic, resistance, aerobic & resistance, or a control group. Pre and Post testing will include stress tests, echos, blood, and urine samples.

Condition Intervention
Lung Cancer
Behavioral: Exercise Training
Behavioral: Progressive Stretching

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lung Cancer Exercise Training Study: A Randomized Trial of Aerobic Training, Resistance Training, or Both in Postsurgical Lung Cancer Patients

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • changes in VO2peak (on exercise capacity) [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
    by comparing the efficacy of different types of exercise training modalities in patients with resected non-small cell lung cancer (NSCLC) following the completion of primary adjuvant therapy.


Estimated Enrollment: 82
Study Start Date: October 2015
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerobic Training
A customized and supervised endurance exercise training program that will last 4 months (16 weeks). The regimen will be tailored to the individual fitness level. The exercise program will consist of three supervised sessions per week. During each session, the participant will cycle on a stationary bicycle at moderate intensity for approximately 30-60 minutes.
Behavioral: Exercise Training
The overall goal for all the exercise training groups will be 3 supervised exercise sessions per week an intensity between 50 to 100% of the individually determined VO2peak for aerobic training and an intensity between 50% to 85% of 1-RM for resistance training. All the exercise interventions are designed such that participants begin exercising at a low intensity (~50%-60% VO2peak / 1RM) that is subsequently increased to more moderate to vigorous intensity (~70%-100% VO2peak / ~70-85% 1RM) when appropriate. All interventions will be individually tailored to each patient following the principles of aerobic or resistance training prescription guidelines for adults.
Experimental: Resistance Training
A customized and supervised resistance exercise training program that will last 4 months (16 weeks). Resistance training will be performed on stationary weight machines. No free weights will be used. The participant will be trained to perform different resistance exercise, alternating between lower and upper body muscle groups. The exercise program will consist of three supervised sessions per week. Each session will last approximately 30-60 minutes.
Behavioral: Exercise Training
The overall goal for all the exercise training groups will be 3 supervised exercise sessions per week an intensity between 50 to 100% of the individually determined VO2peak for aerobic training and an intensity between 50% to 85% of 1-RM for resistance training. All the exercise interventions are designed such that participants begin exercising at a low intensity (~50%-60% VO2peak / 1RM) that is subsequently increased to more moderate to vigorous intensity (~70%-100% VO2peak / ~70-85% 1RM) when appropriate. All interventions will be individually tailored to each patient following the principles of aerobic or resistance training prescription guidelines for adults.
Experimental: Combined Aerobic and Resistance Training
A customized and supervised endurance exercise training program that will last 4 months (16 weeks). The regimen will be tailored to the individual fitness level, and will be a combination of Arm A and Arm B, described above. At each session, the participant will complete aerobic training on a stationary bicycle and also resistance training using stationary weight machines. The exercise program will consist of three supervised sessions per week. Each session will last approximately 30-90 minutes.
Behavioral: Exercise Training
The overall goal for all the exercise training groups will be 3 supervised exercise sessions per week an intensity between 50 to 100% of the individually determined VO2peak for aerobic training and an intensity between 50% to 85% of 1-RM for resistance training. All the exercise interventions are designed such that participants begin exercising at a low intensity (~50%-60% VO2peak / 1RM) that is subsequently increased to more moderate to vigorous intensity (~70%-100% VO2peak / ~70-85% 1RM) when appropriate. All interventions will be individually tailored to each patient following the principles of aerobic or resistance training prescription guidelines for adults.
Active Comparator: Progressive Stretching Group (Attention-Control)
A customized and supervised progressive stretching program that will last 4 months (16 weeks). The progressive stretching program will consist of a series of stretching exercises alternating between lower and upper body muscle groups/joints. This program will consist of three exercise sessions a week. Each session will last approximately 30-60 minutes.
Behavioral: Progressive Stretching
Stretching will be performed on stretching mats (i.e., no machines). Patients will be progressively trained to perform stretching exercises alternating between muscle groups / joints. Stretches will consist of prolonged holds held (under the maximum range of passive motion) initially for 20 secs and increasing to ≥60 secs/stretch.

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent prior to initiation of study-related procedures
  • Age ≥ 21 years MSKCC histologically confirmed postoperative non-small lung cancer
  • An interval of at least one year following the completion of definitive adjuvant therapy (i.e., completion of definitive surgery and/or chemotherapy or radiation)
  • An interval of no longer than ten years following completion of primary therapy
  • Life expectancy ≥ 6 months
  • Sedentary, as per the leisure score index (LSI) of the Godin Leisure-Time Exercise Questionnaire (GLTEQ) (Appendix B) (i.e., patients not performing regular exercise on at least 5 days a week, for at least 30 minutes each session, at a moderate or vigorous intensity for the past month)
  • Exercise intolerance (i.e., patients must have a VO2peak below that predicted for sedentary age and sex-matched individuals)
  • Willing to be randomized to one of the study arms
  • Willing to commit to study program and comply with all related protocol procedures
  • Ability to achieve and complete an acceptable baseline CPET as defined as follows: absence of remarkable ECG findings or results cleared by a cardiologist; hemodynamically appropriate responses to exercise as determined by attending exercise physiologist(s) and reviewing cardiologist; achieving peak or plateau in oxygen concurrent with increased power output; a respiratory exchange ratio ≥ 1.1; volitional exhaustion; and rating of perceived exertion ≥ 18.
  • Ability to achieve and complete an acceptable baseline one-repetition maximum muscular strength test as defined by the effective execution of protocol-specific joint and muscle ranges of motion without remarkable signs or symptoms of pain, discomfort or distress.
  • Primary attending approval

Exclusion Criteria:

  • Presence of a concurrent, actively treated other malignancy, or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer);
  • Presence of metastatic disease;
  • Any of the following absolute contraindications to cardiopulmonary exercise testing:

    • Acute myocardial infarction (within 3-5 days of any planned study procedures);
    • Unstable angina;
    • Uncontrolled arrhythmia causing symptoms or hemodynamic compromise;
    • Recurrent syncope;
    • Active endocarditis;
    • Acute myocarditis or pericarditis;
    • Symptomatic severe aortic stenosis;
    • Uncontrolled heart failure;
    • Acute (within 3 months) pulmonary embolus or pulmonary infarction;
    • Thrombosis of lower extremities;
    • Suspected dissecting aneurysm;
    • Uncontrolled asthma;
    • Pulmonary edema;
    • Room air desaturation at rest ≤ 85%;
    • Respiratory failure;
    • Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis); or
    • Mental impairment leading to inability to cooperate.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068210

Contacts
Contact: Lee Jones, PhD 646-888-8103
Contact: Valerie Rusch, MD 212-639-5873

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Lee Jones, PhD    646-888-8103      
Contact: Valerie Rusch, MD    212-639-5873      
Principal Investigator: Lee Jones, PhD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Duke University
Investigators
Principal Investigator: Lee Jones, PhD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01068210     History of Changes
Other Study ID Numbers: 15-215 
Study First Received: February 11, 2010
Last Updated: April 6, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan Kettering Cancer Center:
Exercise Intervention
Lung Cancer
15-215

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 24, 2016